FDA Announcement Broken on Blog

FDA’s proposed serialized identification number is up for review. As PMP News reports in its new blog, PMP News Insider (www.pmpnews.com/blog), FDA is awaiting your feedback on its “Guidance for Industry: Standards for Securing the Drug Chain – Standardized Numerical Drug Identification for Numerical Drug Packages.

FDA is suggesting the voluntary use of a standardized numerical identifier (SNI) on prescription drug packages. Its draft guidance recommends that the “SNI for most prescription drug packages should be a serialized National Drug Code [sNDC]. The sNDC is composed of the National Drug Code [NDC] that reflects each corresponding manufacturer or repackager, combined with a unique 8-digit numerical serial number generated by the manufacturer or repackager for each individual package.” Expiration dates or lot codes are not suggested for inclusion in the code.

By using sNDCs, FDA believes that such identification can “facilitate authentication and tracking and tracing of drugs.” FDA also believes its suggested SNI is compatible with 2-D bar coding and RFID. Redundant human-readable SNI is encouraged.

FDA has started the year off with a mission focused on securing the supply chain. Also in January, FDA announced its collaborative work with other government agencies in promoting import safety. Part of that effort entails its own draft guidance on Good Importer Practices. In all of these proposals, FDA speaks of securing the supply chain and utilizing track-and-trace technologies.

More guidances are coming, too. FDA scheduled a February meeting on unique medical device identification, taking a lot-based approach. Expect more standards and guidance to come!